AbbVie Files Patent Suit Over Humira Biosimilar

AbbVie Inc has filed a patent-infringement lawsuit against Amgen Inc regarding their biosimilar copy of Humira, claiming that the biosimilar breaches 10 patents of AbbVie despite the FDA’s recommendation for approval of the copy. AbbVie has requested that the courts block the launch of the Humira copy if the FDA issues an approval.

Humira accounts for 60% of AbbVie’s revenue and totaled $8.4 billion in sales in 2015; however, the treatment is also expensive for patients, with a $53,260 a year list price.

Although an FDA panel recently recommended approval for Amgen’s Humira copy, a final decision has not been made.

AbbVie has continually promised to defend Humira from biosimilar competition. Despite many analysts predicting that a Humira copy could come to market by 2018, Amgen insists that they can hold off a copy until 2022.

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Citi analyst Andrew Baum expects to see a large drop in revenue for Humira after biosimilars hit the market. After hitting an estimated $16 billion in sales in 2017, the drug-maker is forecasted to decrease to around $6 billion in sales by 2022.

If the biosimilar is approved, the launch will likely be delayed due to the patent-infringement challenge. Further delays are possible if AbbVie files additional infringement lawsuits involving more patents after FDA approval.

Last year, after the approval of the first biosimilar — Novartis AG’s copy of Amgen’s cancer care drug Neupogen — sales were delayed for 6 months before hitting the marketplace.  The  biosimilar hit the market with a list price 15% lower than Neupogen. Recently, CVS made the decision to drop name brand drugs in favor of cost-effective biosimilars, including Novartis AG’s Neupogen copy, Zarixo.

Additionally, Amgen isn’t AbbVie’s only competition in regards to Humira. Novartis;Merck and its partner Samsung Bioepis along with partners Baxalta and Momenta Pharmaceuticals all currently have Humira biosimilars in development. -Julie Gould

References:

United States District Court. ABBVIE INC. and ABBVIE BIOTECHNOLOGY LTD. v. AMGEN INC. and AMGEN MANUFACTURING LTD. https://www.bigmoleculewatch.com/wp-content/uploads/2016/08/ded-1-99-cv-de431-1.pdf. August 2016.

Staton T. Aiming to shield $14B in sales, AbbVie smacks Amgen with a patent suit over Humira biosim. FiercePharma. Published August 8, 2016. Accessed August 9, 2016.

Rockoff JD. AbbVie Files Patent Suit Over Amgen’s Copy of Humira. The Wall Street Journal. Published August 5, 2016. Accessed August 9, 2016.